| Device |
tissue adhesive, aortic aneurysmorrhaphy |
| Definition |
For use as an adjunct in the surgical repair of thoracic aortic aneurysms. |
| Physical State |
a two-part liquid that is mixed just prior to use |
| Technical Method |
the adhesive is introduced into the false lumen after collapsing the false lumen to minimize the amount of adhesive needing to be dispensed |
| Target Area |
false lumen of an aortic aneurysm |
| Review Panel |
Cardiovascular |
|---|
| Product Code | ODT |
|---|
| Submission Type |
HDE
|
|---|
| Device Class |
3 (De Novo Petitions Granted)
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
